A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Lee, Jae Jin; Kim, Sang Yong; Chung, Hyun Cheol; Lee, Kyung Hee; Song, Hong Suk; Kang, Won Ki; Hong, Young Seon; Choi, In Sil; Lee, Young Yeul; Woo, In Sook; Choi, Jin Hyuk

doi:10.1007/s00280-008-0818-3

Cited by 13 publications

(11 citation statements)

References 20 publications

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“…Unfortunately, there are no data directly comparing the anti-tumor activity of 5-FU plus taxane (paclitaxel or docetaxel) with that of S-1 plus taxane. Although there are limitations in comparing the results of different studies, the efficacy of S-1 plus paclitaxel has been reported in phase II trials with a response rate of 40–55% and a median survival of 9–15 months, and this is comparable to the present data for FLTAX [31,32,33]. Accordingly, the FLTAX regimen may be a good option for GC patients who are not suitable for treatment with platinum agents.…”

Section: Discussionsupporting

confidence: 76%

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Matsubara¹,

Shimada²,

Kato³

et al. 2011

Oncology

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Objective: We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients. Methods: Patients with untreated stage IV GC received paclitaxel 80 mg/m² as a 1-hour infusion, followed by 5-FU 600 mg/m² as a bolus infusion and L-leucovorin 250 mg/m² as a 2-hour infusion on days 1, 8 and 15. Treatment cycles were repeated every 28 days. The primary endpoint was response rate. Results: Thirty-five patients were enrolled. The median age was 62 years (range 34–75). Twenty-one patients (60%) had diffuse-type cancer and 11 had peritoneal metastasis. The confirmed response rate was 43% (95% CI 26–61) with 15 partial responses. Stable disease was observed in 16 (46%) patients. Median progression-free survival and overall survival were 6.8 months (95% CI 5.8–7.4) and 16.2 months (95% CI 10.0–22.8), respectively. Grade 3–4 adverse events were: neutropenia (54%), febrile neutropenia (3%), diarrhea (6%) and sensory neuropathy (11%). Conclusion: FLTAX showed a desirable safety profile, and the efficacy against advanced GC was encouraging. FLTAX may be a good option for GC patients with deteriorated general condition, and a randomized clinical trial in such patients is currently underway.

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Section: Discussionsupporting

confidence: 76%

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Matsubara¹,

Shimada²,

Kato³

et al. 2011

Oncology

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“…Many phase II studies have also been performed to investigate the safety profi le and effectiveness of weekly paclitaxel-containing combination therapies for advanced and metastatic gastric cancers (Table 4) [ [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61].…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

“…Studies of combinations with oral S-1 (tegafur, gimeracil, oteracil) have also been performed [47,49,[55][56][57][58][59]. In these trials, response rates ranged from 40% to 65% and MSTs ranged from 8.9 to 15.5 months.…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

Paclitaxel chemotherapy for the treatment of gastric cancer

2009

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cause of cancer mortality. Although the incidence of gastric cancer has been declining in most developed countries, esophago-gastric junctional tumor and tumor in the cardia has, conversely, been increasing [2] and these tumors still remain one of the biggest problems worldwide.The prognosis of patients with advanced (i.e., unresectable or metastatic) gastric cancer is very poor. The median survival time for such patients is 6 to 9 months [3]. For many years, various chemotherapeutic agents have been used in attempts to improve survival, progression free-survival, response rate, and quality of life in patients with advanced gastric cancer as well as to improve disease-free survival in patients in whom curative resection of the cancers has been performed. 5-Fluorouracil (5-FU) and cisplatin-based regimens have long been considered reference treatments. Commonly used regimens have included epirubicin, cisplatin, and continuous infusion of 5-FU; 5 days' infusion of 5-FU plus cisplatin every 4 weeks; a weekly infusion regimen of 5-FU/leucovorin (LV) over 24 h plus cisplatin every 2 weeks; and 5-FU bolus plus 22-h infusion of 5-FU on days 1 and 2, in combination with cisplatin every 2 weeks. The results with these regimens, together with other study results, suggested that combination regimens including fl uorinated pyrimidines, cisplatin, doxorubicin, epirubicin, and methotrexate, had better response rates than single agents. Although gastric cancer is a relatively chemosensitive disease, with response rates of 30% to 40%, these treatments have shown a modest but unsatisfactory increase in overall survival [4]. In this regard, chemotherapy in the advanced gastric cancer setting is limited by a low complete response rate, response durations that are shortlived, and considerable toxicities.Nevertheless, recently, the development of new chemotherapeutic and molecular targeting agents has opened the door to various clinical trials to fi nd novel therapeutic strategies to improve the outcome of Abstract A comprehensive review of phase I and phase II clinical trials of paclitaxel and paclitaxel-containing chemotherapy regimens for advanced gastric cancer was performed. Response rates, median progression-free survivals, and median overall survivals were examined, together with the treatment regimens and the numbers of patients registered in each trial. Although paclitaxel monotherapy produced considerable improvement in tumor response and prognosis, combination doublet or triplet chemotherapy with fl uoropyrimidines and/ or platinum compounds showed better results than the paclitaxel monotherapy. With regard to the schedule of paclitaxel administration, weekly injection seemed to show less toxicity and better results than administration every 3 weeks. Adjuvant therapies, chemoradiation therapies, and paclitaxel treatment for gastric ascites were also investigated and are discussed.

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“…In Japan, S1 became the key drug in gastric cancer treatment regimens following the Japan Clinical Oncology Group (JCOG) 9912 trial which demonstrated that S1 is not inferior to 5-FU (16). Additionally, the findings from two phase II studies suggested that S1 plus PTX is an effective regimen for advanced gastric cancer treatment (17,18). In Japan and other countries, the standard treatment regimen for gastric cancer typically contains platinum, primarily CDDP.…”

Section: Discussionmentioning

confidence: 99%

Chemotherapy Treatment of a Pregnant Woman with Progressive Gastric Cancer

et al. 2015

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We herein describe a rare case of gastric cancer that was treated with chemotherapy during pregnancy. A woman in her thirty's at 23 weeks of gestation was admitted to the hospital with epigastralgia and left cervical lymph node swelling. She had been previously diagnosed with metastatic adenocarcinoma at another hospital. Findings from a CT scan and esophagogastroduodenoscopy revealed progressive gastric cancer, and the pathology indicated poorly differentiated adenocarcinoma. Chemotherapy was administered at 24 weeks of gestation, without the development of severe toxicity. At 32 weeks of gestation, a healthy baby girl (birth weight 1,442 g, Apgar score 7/8) was delivered by caesarean section. The child continued to show no abnormalities at 12 months after delivery.

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A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Cited by 13 publications

References 20 publications

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Paclitaxel chemotherapy for the treatment of gastric cancer

Chemotherapy Treatment of a Pregnant Woman with Progressive Gastric Cancer

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